New NIH Data Management and Sharing (DMS) Policy Overview
NIH has issued the Data Management and Sharing (DMS) Policy (effective January 25, 2023) to promote the sharing of scientific data. Sharing scientific data accelerates biomedical research discovery, in part, by enabling validation of research results, providing accessibility to high-value datasets, and promoting data reuse for future research studies.
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Effective Date: January 25, 2023
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Required for: for All New and Competing Continuation applications due ON or AFTER JANUARY 25, 2023
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NOT Required for: for Existing awards or Non-Competing Continuations (RPPRs)
NIH Policy Key Points
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NIH Final Notice: NOT-OD-21-013. Also, refer to the Breakdown of Notice: NOT-OD-21-013 (PPT)
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NIH expects Investigators and Institutions to:
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Plan and budget for the managing and sharing of data
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Submit a DMS plan (DMSP) for review when applying for funding
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Comply with the approved DMS plan
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DMSP has to be TWO PAGES or less -> new “FORMS-H” package to be used
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The DMSP is NOT part of the scoring of an application – NOT seen by peer reviewers (they may comment on budget items)
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NIH program staff will review the DMSP for acceptability and may request modifications prior to award as appropriate.
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DMSPs must be approved by the funding institute prior to award
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Include in the DMSP your proposed approach to data management & sharing
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The DMSP can be updated during the course of the award/support period to reflect any changes in the management and sharing of scientific data
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new scientific direction?
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new repository option?
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timeline revision?
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DMSP Policy represents the minimum requirements for the NIH
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Funding Opportunity Announcements (FOAs)/NIH Institutes, Centers, or Offices (ICOs) may require specific data sharing requirements that are in addition to the basic policy
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NIH encourages data management and sharing practices to be consistent with the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles
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Manage and share data as described in the approved DMSP
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Provide updates on data management and sharing activities in annual progress reports (RPPRs)
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If a DMSP changes over the course of the project, work proactively with NIH Program Officer to obtain review and approval of modifications
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Your primary resource for approaching the assembly of your DMSP can be found at the NIH Data Management and Sharing Policy Overview Website
Breakdown of Information
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General Summary
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Description & Rationale
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List MetaData
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Related Tools, Software and/or Code
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Standards
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Preservation, Access, and Associated Timelines
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Access, Distribution, or Reuse Considerations
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Oversight of Data Management and Sharing
Resource
Breakdown of Notice PPT
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Unique Persistent Identifiers (PID)
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Long Term Sustainability
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Metadata
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Curation and Quality Assurance
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Free and Easy Access
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Broad and Measured Reuse
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Clear Use Guidance
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Security and Integrity
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Confidentiality
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Common Format
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Provenance
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Retention Policy
Resources
Breakdown of Notice PPT
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ALL COSTS Must be incurred PRIOR to end date of project
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Must be Reasonable, Allowable, Allocable, and Consistent
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Must not include
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infrastructure costs that are included in institutional F&A
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costs associated with the routine conduct of research
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may not be charged as both direct and indirect costs
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May include
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Curating data and developing supporting documentation
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formatting data
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de-identifying data
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preparing metadata for discoverability, interpretation, & reuse
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formatting data for sending to & storage at a selected repository for long-term preservation & access.
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Local data management considerations
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unique and specialized information infrastructure
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Preserving and sharing data through established repositories
Resource
Breakdown of Notice PPT
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Getting Started
NIH Resources
DMPTool
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Resources and Contacts
Countway Library Resources
Harvard University-wide Resources
NIH Resources
Harvard University Contacts
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General Policy Questions:
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Patrick O’Neill, Director of Research Administration Harvard Chan Office of Research Administration
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Information/Data Security:
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Andy Ross, Senior Information Security Manager Harvard Chan Department of Information Technology
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Human Subjects/PHI:
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Kim Serpico, Associate Director of IRB Operations Harvard Chan Office of Regulatory Affairs and Research
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Leslie Howes, Director of Harvard Chan Office of Regulatory Affairs and Research
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Writing Resources:
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Vanessa Barton, Assistant Director of Faculty Programs and Proposal Support, Office of Research Strategy and Development
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Content & Data Services:
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